Clinical Trial: Safety, Efficacy and Pharmacokinetics of BTA-C585 in a RSV Viral Challenge Study
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Antiviral Activity Against Respiratory Syncytial Virus Infection, and the Pharmacokinetics of Multiple Oral Do
Brief Summary: The primary purpose of this study is to evaluate the antiviral activity of oral BTA-C585 compared to placebo in healthy volunteers after intranasal challenge with RSV-A Memphis 37b virus.
Detailed Summary:
Sponsor: Biota Pharma Europe Limited
Current Primary Outcome: Area under the curve (AUC) viral load of RSV-A Memphis 37b [ Time Frame: Days 2-13 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Area under the curve (AUC) of total RSV symptom scores [ Time Frame: Days 1-13 ]
- Number of adverse events [ Time Frame: Screening to Day 28 ]
Original Secondary Outcome: Same as current
Information By: Aviragen Therapeutics
Dates:
Date Received: March 21, 2016
Date Started: March 2016
Date Completion:
Last Updated: January 23, 2017
Last Verified: January 2017
